ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV (ETOC)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 2

Conditions: Hepatitis

Treatments: Drug: Peg-interféron alpha 2a + ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00901524

2008-000859-10

ANRS HC 20

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

Full description

In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments.

However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years
• Weight 85 kg below the pre-inclusion visit.
• Documented HIV infection (HIV positive)
• HCV infection documented by a positive PCR
• HCV Genotype 1 or 4
• Compensated liver disease (Child-Pugh below/equal to 6)
• Lymphocytes CD4 above 200/mm3
• Patient not answering a treatment for hepatitis C.
• Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

Exclusion criteria

• Co-infection with HBV (HBsAg positive)
• Neutropenia below 1000/mm3
• Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3.
• Hemoglobin below 11 g / dL (men and women)
• Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell
• Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

PegIFN- alpha 2a + RBV

No Intervention group

Treatment:

Drug: Peg-interféron alpha 2a + ribavirin